MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-27 for HOSPIRA/PLUM A+3 W/MEDNET DWL-AG132 manufactured by Hospira, Inc..
[48224663]
Patient Sequence No: 1, Text Type: N, H10
[48224664]
The nurse was called to the bedside to address a shrill alarm. The rn found the triple channel pump alarming malfunction and no longer infusing the iv fluids or inotrope drips. Alarm code on the pump read "malfunction e321". New pump obtained and iv fluids re-started. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5750617 |
| MDR Report Key | 5750617 |
| Date Received | 2016-06-27 |
| Date of Report | 2016-06-10 |
| Date of Event | 2016-04-09 |
| Report Date | 2016-06-10 |
| Date Reported to FDA | 2016-06-10 |
| Date Reported to Mfgr | 2016-06-10 |
| Date Added to Maude | 2016-06-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOSPIRA/PLUM A+3 W/MEDNET |
| Generic Name | PUMP, INFUSION |
| Product Code | PHC |
| Date Received | 2016-06-27 |
| Model Number | DWL-AG132 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA, INC. |
| Manufacturer Address | 375 N FIELD DR. LAKE FOREST IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-27 |